Alam and Ahmad, IJPSR, 2013; Vol. 4(7): 2441-2449.

ISSN: 0975-8232

IJPSR (2013), Vol. 4, Issue 7 (Review Article)

Received on 01 March, 2013; received in revised form, 21 April, 2013; accepted, 17 June, 2013

PHARMACEUTICAL TECHNOLOGY TRANSFER: AN OVERVIEW

Md. Shoaib Alam*1 and Javed Ahmad 2
PDL – Formulation; Ranbaxy Laboratories Limited 1, Paonta Sahib-173025, Himachal Pradesh, India
Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard (Hamdard University) 2, New Delhi -
110062, India
Keywords:
Technology Transfer, Technology
Transfer Process, Stages of Technology
Transfer, Technology Transfer Dossier
Correspondence to Author:
Md. Shoaib Alam
Research Scientist, PDL-Formulation;
Ranbaxy Laboratories Limited, Paonta
Sahib-173025, Himachal Pradesh,
India
E-mail: shoaib.Alam@ranbaxy.com
ABSTRACT: The article attempts to discuss the issues associated with
technology transfer in the pharmaceutical industry. A major decision
focuses on that point where the idea or process is advanced from a
research- oriented program to target toward commercialization. The
success of any program is highly dependent on the effectiveness of the
communication preceding its implementation. The ultimate goal for
successful technology transfer is to have documented evidence that the
manufacturing processes for drug substances and drug product,
respectively, are robust and effective in producing the drug substances
and drug product complying with the registered specifications and Good
Manufacturing Practice requirements. The Pharmaceutical Technology
Transfer activities are to transfer product and process knowledge between
development and manufacturing, and within or between manufacturing sites to
achieve product realisation. This knowledge forms the basis for the
manufacturing process, control strategy, process validation approach and
ongoing continual improvement. To take all the gathered knowledge and use it
as the basis for the manufacturing control strategy, the approach to process
qualification and on-going continuous improvement.

INTRODUCTION: The technology transfer
throughout the life cycle as well as transfers of
manufacturing processes from one site to another
during the commercial production phase 1.
In the pharmaceutical industry, “technology transfer”
refers to the processes that are needed for successful
progress from drug discovery to product
development to clinical trials to full-scale
commercialization 2.
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DOI:
10.13040/IJPSR.0975-8232.4(7).2441-49
Article can be accessed online on:
www.ijpsr.com
This knowledge forms the basis for the
manufacturing process, control strategy, process
validation approach and ongoing continual
improvement 3. The goal of technology transfer
activities is to transfer product and process
knowledge between development and manufacturing,
and within or between manufacturing sites to achieve
product realization.
This review articles is also intended to propose some
regulations to realize technology transfer necessary
for high quality and stable manufacturing of
developed products and existing products by
reviewing technology transfer based on the following
ideas.

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Alam and Ahmad, IJPSR, 2013; Vol. 4(7): 2441-2449.
 The technology transfer means actions to
transfer information and technologies necessary
to realize quality of design of drugs during
manufacturing.
 Appropriate technology transfer is important to
upgrade the quality of design to be the quality of
product, and ensure stable and high quality of
the product.
 It should be noted that drugs may influence
human lives and health, and their raw materials,
compositions and manufacturing methods are
changed during their long term manufacturing
and marketing.
 To assure the drug quality, it is desired to make,
that is what, when and why information should
be transferred to where and by whom and how to
transfer, then share knowledge and information
of the drug product between transferring and
transferred parties.
 The technology transfer does not mean one time
actions taken by the transferring party toward
the transferred party, but means continuous
information exchange between the both parties
to maintain the product manufacturing.
Definition of Technology Transfer: Technology
transfer usually involves some source of technology
that possess specialized technical skills, which
transfers the technology to a target group that do not
possess those specialized technical skills, and who
therefore cannot create the tool themselves 4, 5.
Technology transfer often involves the licensing of
intellectual property rights and extending property
rights and technical expertise to developing firms. In
the pharmaceutical industry, “technology transfer”
refers to the processes of successful progress from
drug discovery to product development, clinical trials
and ultimately full-scale commercialization 6. It is
the process by which an original innovator of
technology makes its technology available to
commercial partner that will exploit the technology 7.
Basic Policies on the Establishment of the
Guideline for the Technology Transfer
 Assurance of consistency through
development and manufacturing.
International Journal of Pharmaceutical Sciences and Research
ISSN: 0975-8232
 Embodiment of Quality by Specifications.
 Documentation Management and Update of
Technical Information.
Technology Transfer Process: The drug quality is
designed based on basic data concerning efficacy and
safety obtained from various studies in preclinical
phases and data concerning efficacy, safety and
stability of drug products obtained from clinical
studies. The quality of design will be almost
completed in Phase II clinical study. Various
standards for manufacturing and tests will be
established in process of reviewing factory
production and Phase III study to realize the quality
of design, and the quality of design will be verified
in various validation studies, and will be upgraded to
be the quality of product, and the actual production
will be started. The technology transfer consists of
actions taken in these flows of development to
realize the quality as designed during the
manufacture. Even if the production starts, the
technology transfer will take place in processes such
as changes in manufacturing places. The processes
are classified broadly into the following five
categories.
1. Quality Design (Research Phase): The quality
design is to design properties and functions of
drugs, and often performed in phases from late
preclinical studies to Phase II study. For drug
products, the quality design corresponds to so-
called pharmaceutical design to design
properties and functions such as elimination of
adverse reactions, improvement of efficacy,
assurance of stability during distribution, and
adding usefulness based on various data such as
chemical and physical properties, efficacy,
safety and stability obtained from preclinical
studies 8. For drug substances, the quality design
is to determine starting materials and their
reaction paths, and basic specifications of the
drug substances.
2. Scale-up and Detection of Quality Variability
Factors (Development Phase):
a. Research for Factory Production: To
manufacture drugs with qualities as designed, it
is required to establish appropriate quality
control method and manufacturing method,
after detecting variability factors to secure
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stable quality in the scale-up validation that is
performed to realize factory production of
drugs designed on the basis of results from
small-scale experiments. In general, this
process is called the research for factory
production where the quality of design will be
upgraded to be the quality of product.
b. Consistency between Quality and
Specification: When the product specification
is established on the basis of the quality of
product determined in the above, it is required
to verify that the specification adequately
specifies the product quality. In short, the
consistency between quality and specification
is to ensure in the product specification that the
quality predetermined in the quality design is
assured as the manufacturing quality, and the
product satisfies the quality of design.
Manufacturing methods are established with
limited amount of lots and limited resources of
raw materials, the product specification should
be established based on data from study results
with limited lots; however, relations between
upper and lower limits of manufacturing
formula (compositions and manufacturing
methods) and upper and lower of control limits
of the product specification should be fully
understood, and the consistency between the
product quality and specification should be
maintained.
Also, since initial manufacturing formula and
specification are established based on limited
information, the consistency between the
quality and specification should be fully
verified after the start of manufacturing, and
the consistency should be revised through
appropriate change controls, if necessary.
c. Assurance of consistency through
development and manufacturing: To make
developed product have indications as
predetermined in clinical phases, the quality of
design should be reproducible as the quality of
product (assurance of consistency). For this
purpose, the transferring party in charge of
development should fully understand what kind
of technical information is required by the
transferred party in charge of manufacturing,
and should establish an appropriate evaluation
International Journal of Pharmaceutical Sciences and Research
ISSN: 0975-8232
method to determine whether a drug to be
manufactured meets the quality of design.
3. Technology Transfer from R&D to
Production: Transfer of technical information is
necessary to realize manufacturing formula
established in the above in the actual production
facility. When transfer technology of new
products from research and development
department to production department, technical
information to be transferred should be complied
as research and development report
(development report and recommend using the
development report as a part of technology
transfer documentations).
4. Validation and Production (Production
Phase): Production is implemented after various
validation studies verify that it is able to stably
produce based on transferred manufacturing
formula. While the manufacturing facility
accepting technology is responsible for
validation, the research and development
department transferring technology should take
responsibility for validations such as
performance qualification (PQ), cleaning
validation, and process validation (PV) unique to
subject drugs. For validations such as
installation qualification (IQ) and operational
qualification (OQ), which are not unique to the
subject drugs, it is possible to effectively use
data of already implemented validations.
5. Feedback of Information Generated from
Production Phase and Technology Transfer
of Marketed Products: As a result of
technology transfer, products are manufactured
and brought to the hands of consumers. Since
the technical information of developed products
are obtained from data of a limited amount of
batches, various standards have been established
from the limited data, and quality evaluation
method established in development phase is not
always sufficient for factory production, it is
highly desired to feedback and accumulate
technical information obtained from repeated
production, if necessary.
Also, it is important to appropriately modify
various standards established before on the basis
of these information, and accountability
(responsibility for giving sufficient explanation)
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and responsibility (responsibility for outcomes
of actions) for design and manufacturing should
be executed. For this purpose, appropriate
feedback system for technical information and
documentation management of technology
transfer should be established. For drugs as they
have long product shelf life, documentation
management should be performed assuming that
the technology transfer would occur several
decades after the completion of development.
Also since product improvements and changes
of specifications and methods are often
implemented, the initial technical information
should be reviewed and updated at regular
intervals.
For this kind of documentation management and
information updating, it is desirable to establish
product specification describing entire
characteristics of the product in addition to the
development report, which is to be revised and
updated regularly. Also as in the case of
technology transfer from research and
development to production, responsibilities for
the technology transfer should be clearly
defined, documentation of technology transfer
should be prepared, and the technology transfer
should be implemented through adequate
exchanges of technical information.
FIGURE 1: TECHNOLOGY TRANSFER PROCESS
Actually, technological evaluation, requirements and
capacities recognition and selection of technology
methods are of vital importance in the technology
transfer process 10. Thus, awareness of effective
factors on technology transfer is of great importance
TABLE 1: EFFECTIVE FACTORS IN TECHNOLOGY TRANSFER 11, 12
International Journal of Pharmaceutical Sciences and Research
ISSN: 0975-8232
Effective Factors in Technology Transfer: Eight
factors are critical in terms of creating favorable
conditions for pharmaceutical technical transfers 9:
1. A viable and accessible local market;
2. Political stability, good economic
governance;
3. Clear development priorities;
4. Effective regulation;
5. Availability of skilled workers;
6. Adequate capital markets;
7. Strong intellectual property rights (IPR) and
effective enforcement;
8. Quality of the relationship between industry
and government, and the extent they are able
to work together effectively for long periods
of time.
In the technology transfer process, the entire
elements of the technology triangle (Figure 1) are to
be transferred into organizations and not impose
them solely into technology’s hardware parts. Thus,
they should be fully cognizant of their capabilities
and requirements before launching technology
transfer.
for technology recipients. The paper identified and
classified effective factors on technology transfer
into seven main criteria each of which covers a set of
sub-criteria which have been indicated in Table 1.
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Factors and Main Criteria Sub-Criteria

Factors relative to technology Long-run strategic planning in technology development; Investment in R&D; and
recipient organization Development of managerial and organizing skills in organizations.
Capability in absorption of importing technology; Establishing relationship between
Factors of Absorption and
production and research; Training of individual relative to technology; and Interaction
Application
with different international centers in technology cooperation areas.
Information development in the field of technology transfer methods; Modification of
Cultural Factors cultural value systems in organizations; and Diffusion of scientific attitude in
organizations.
Localizing importing technology; Employment of entrepreneur managers; and Creation
Structural Factors
of standards and capabilities in companies.
Organizational infrastructure; Equipmental infrastructure; Informational infrastructure;
Infrastructural Factors
and Human infrastructure.
Personnel training in international valid companies; Employment of international
Global Factors specialist in the field of technology; and Creation of appropriate relationship between
recipient and sender technology.
Degree of achieving technology; Degree of transferred technology price; Degree of
Technological Factors simplicity and complicity of the technology; and Degree of development and
improvement of technology on the basis of internal requirements.

The Anatomy of Technology Transfer in the
Pharmaceutical Sector:
It’s much more than simply handing over
technology - The transfer of R&D pharmaceuticals
is providing a “tool box”. It occurs through many
channels, all of which result in improving the
economic capabilities of the recipient. Following one
definition 13, we identify the following elements;
Strong market mechanisms provide the starting
point - Foreign Direct Investment (FDI) is by far the
main channel of technology transfer, but other
“market mechanisms” such as licensing agreements,
royalties and joint ventures are necessary channels
for transferring R&D pharmaceutical technologies.
Through regulation and investment, governments can
help to create the right conditions for technology
markets to function.

 “Techno-ware”: for the pharmaceutical Complex map of technology transfer - The

industry this would include the transfer of
physical objects such as equipment for use in
research laboratories or production equipment
for manufacture of pharmaceuticals
ingredients, or formulation or packaging of
final products;
 “Human-ware”: skills and human aspects of
technology management and learning, such as
a training course for researchers or general
practitioners across the world Technology
transfer can also create positive spillover
effects into associated industries and into the
supporting public sector research
infrastructure;
 “Info-ware”: all techniques related to
knowledge, information and technology; in
the form of a technology license;
 ”Orga-ware”: organizational and procedural
knowledge needed to operate a given
technology relating to a chemical or
biological compound.
research-based pharmaceutical industry, like most
other industries, is seeing the newly industrialized
countries and other middle-income countries
increasingly relying on technology transfer to access
advanced foreign technologies and grow their
domestic capabilities. The research-based
pharmaceutical industry’s track record is proof that
in the public health arena, the historical demarcation
lines such as “North-South” are being replaced by
more complex networks of technology transfer. The
above trend is not always shared by low income
countries, and is therefore sometimes characterized
by an exposure to foreign technologies and weak
absorptive capacity. This creates a particular
challenge for R&D pharmaceutical technology
transfer and means that those parts of the world least
equipped to benefit today from technology transfer
are among those who need its products the most.
The Right Conditions for Pharmaceutical
Technical Transfer- Commercial opportunities are
paramount for the private sector when considering
technology transfer, but if the basic conditions are

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right, non-commercial reasons may also play a part.
This is particularly true in advanced technology
sectors, especially when this might provide an
opportunity to open a market to a specific
technology. Many countries are already well
positioned in terms of R&D pharmaceutical
technology transfers. Pharmaceutical and vaccine
manufacturers consider a variety of factors in
evaluating potential technology transfer ventures.
Many of these are influenced by government policy
decisions. The most effective role for governments is
one of creating optimal enabling conditions, linked to
the country’s overall economic policy objectives.
A government’s willingness to create optimal
conditions to attract technology is a strong
determinant of whether transfers will be directed
towards their domestic industrial sector. For all
investors, political stability and the rule of law are
prerequisites. What research-based pharmaceutical
companies are looking for in prospective recipient
countries includes:
 Promising market scale and accessibility;
 Political stability and good, transparent
governance;
 Appropriate capital markets;
 Innovation-friendly environment with
adequate intellectual property rights and
effective enforcement;
 Proper access to information;
 Adherence to high regulatory standards;
 Skilled workforce;
 Clear economic development priorities.
Stages of Technology Transfer: Typically,
technology transfer occurs during one of five stages
in the product's lifecycle: early discovery,
toxicological evaluation, clinical development, scale-
up and commercial manufacturing, and in-line
production 4, 5. Each stage involves a different type
of transfer, rationale, and key participants. This
transfer stages consists of good-practice guidelines
and comprehensive templates that integrate the
concurrent transfer work streams of drug substance,
International Journal of Pharmaceutical Sciences and Research
ISSN: 0975-8232
drug product, analytical methods, and packaging
requirements.
The key activities for each of these work streams are
aligned with good laboratory practices or current
good manufacturing practices to ensure consistent
and controlled manufacturing of a high-quality
product. In addition, there are specific activities to
address program management, documentation, and
site readiness requirements. These stages help to
optimize these transfer work streams and activities
by:
 Addressing potential manufacturing
equipment and processing constraints in the
initial process design stages
 Ensuring that only the necessary transfer
activities will be executed to avoid interfering
with new product launches
 Managing compliance and regulatory
activities
 Allocating assets more efficiently to support
both ongoing production and transfer
activities
 Establishing integrated plans (key activities,
dependencies, inputs/outputs, and
deliverables) between the sending and
receiving parties.
Technology Transfer Documentation: To properly
transfer technology according to the above processes,
documentation of technology transfer including
appropriate procedures and technical documents is
necessary. Procedures and documentation of
technology transfer are indicated as follows. The raw
data of the documents (such as development report)
should be prepared and compiled according to
purposes, and should be always readily available and
traceable. For successful technology transfer, task
assignments and responsibilities should be clarified,
and acceptance criteria for the completion of
technology transfer concerning individual technology
to be transferred.
In principle, it is desirable to prepare product
specification with detailed information of product
(drug substances or drug products) subject to
transfer, then proceed with the technology transfer
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according to the technology transfer plan established
on the basis of this specification, and document the
results as the technology transfer report. For that
purpose, the following technical information should
be transferred.
 The R&D department should clarify
considerations of GMP compliance specific
to subject drugs and manufacturing methods
(manufacturing processes), and present them
to a facility and equipment department.
 The facility and equipment department
should establish facilities and equipments
reflecting the above considerations, clearly
details of the establishment and operational
considerations of those facilities and
equipments, and present them to a drug
manufacturing department.
 The drug manufacturing department should
fully understand the above information,
implement validations, and perform
appropriate operations and controls in
conformity to the established facilities and
equipments, and records results of operations
and controls.
(1) Research and Development Report: The
research and development report (development
report) is a file of technical information
necessary for drug manufacturing, which is
obtained from pharmaceutical development, and
the research and development department is in
charge of its documentation. This report is an
important file to indicate rationale for the quality
design of drug substances and drug products
including information such as raw materials,
components, manufacturing methods,
specifications and test methods. The following
exemplifies information to be contained in the
development report.
 Historical data of pharmaceutical
development of new drug substances and
drug products at stages from early
development phase to final application of
approval
 Raw materials and components
 Synthetic route
International Journal of Pharmaceutical Sciences and Research
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 Rationale for dosage form and formula
designs
 Rationale for design of manufacturing
methods
 Rational and change histories of important
processes and control parameters
 Quality profiles of manufacturing batches
(including stability data)
 Specifications and test methods of drug
substances, intermediates, drug products, raw
materials, and components, and their
rationale (validity of specification range of
important tests such as contents, impurities
and dissolution, rationale for selection of test
methods, regents, and columns, and
traceability of raw data of those information)
(2) Product Specification (Product Specification
File): The product specification is to compile
information which enables the manufacture of
the product, and to define specification,
manufacturing and evaluation methods of the
product and its quality, and the transferring party
is responsible for documenting the file 14. The
product specification file should be reviewed at
regular intervals, and incorporate various
informations obtained after the start of
production of the product, and be revised as
appropriate. The product specification file
should contain the following.
 Information necessary for the start and
continuation of product manufacturing
 Information necessary for quality assurance
of the product
 Information necessary for assurance of
operation safety
 Information necessary for environmental
impact assessment
 Information of costs
 Other specific information of the product
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(3) Technology Transfer Plan: The technology
transfer plan is to describe items and contents of
technology to be transferred and detailed
procedures of individual transfer and transfer
schedule, and establish judgment criteria for the
completion of the transfer. The transferring party
should prepare the plan before the
implementation of the transfer, and reach an
agreement on its contents with the transferred
party 15.
(4) Technology Transfer Report: The technology
transfer report is to report the completion of
technology transfer after data of actions taken
according to the technology plan is evaluated
and the data is confirmed pursuant to the
predetermined judgment criteria 16. Both
transferring and transferred parties can
document the technology transfer report;
however, they should reach an agreement on its
contents 17.
(5) Approval by Quality Assurance Department:
It is desirable that the quality assurance
department should establish confirmation
process for all kinds of technology transfer
documentation, and should check and approve
the documentation.
Technology Transfer Dossier (TTD): The
site/designee shall receive a Technology Transfer
Dossier from R & D to another manufacturing site.
The following items are part of dossier.
 Molecule information
 Proposes Markets
 Master Formula Card
 Master Packaging Card
 Storage Requirements
 Expiry
 Raw Material/Packaging and labeling
Specifications proposal
International Journal of Pharmaceutical Sciences and Research
ISSN: 0975-8232
 Environmental, Health and safety
requirements
 Proposed Master Formula
 Detailed description of the process
 Critical parameters of the process
 Shipping requirements
 Standard test procedures for Raw
materials/packing materials/in-
process/Finished product specifications.
 Finished Product Specifications
 Special Sampling requirements if any
 Stability testing requirement
 Product Development Report.
CONCLUSION: In pharmaceutical industry,
technology transfer means action to transfer of
information and technologies necessary to realize
quality of design of drugs during manufacturing. The
three primary considerations to be addressed during
an effective technology transfer are the plan, the
persons involved, and the process. A plan must be
devised to organize the personnel and the process
steps. Once prepared, the plan must be
communicated to the involved parties in research, at
the corporate level and at the production site. The
technology transfer does not mean one-time actions
taken by the transferring party toward the transferred
party, but means continuous information exchange
between both the parties to maintain the product
manufacturing. To assure the drug quality, it is desire
to make sure that is what, when, and why
information should be transferred to where and by
whom and how to transfer, then share knowledge and
information of the technology transfer each other
between stake holders related to drug manufacturing.
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How to cite this article:

Alam MS and Ahmad J: Pharmaceutical Technology Transfer: An Overview. Int J Pharm Sci Res 2013: 4(7); 2441-2449. doi:
10.13040/IJPSR. 0975-8232.4(7).2441-49
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